Nicotine
- Product NDC
- 55910-918
- 11-digit product format
- 559100918
- Labeler code
- 55910
- Product ID
- 55910-918_310d5dd0-1108-441e-8b95-e1f9c63c7f9c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Nicotine Polacrilex
- Dosage form
- GUM, CHEWING
- Route
- ORAL
- Labeler
- Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
- Application
- ANDA079038
- Marketing category
- ANDA
- Marketing start
- 2023-05-01
- Marketing end
- 2028-07-28
- Substance
- NICOTINE
- Active strength
- 4 mg/1
- Pharmacologic classes
- Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nicotine
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NICOTINE | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6M3C89ZY6R |
| Rxcui | 311975 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55910-918-20 | Nicotine | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 5 |
| 55910-918-20 | Nicotine | 20 in 1 CARTON | GUM, CHEWING | 20 | | 5 |
| 55910-918-40 | Nicotine | 40 in 1 CARTON | GUM, CHEWING | 40 | | 5 |
| 55910-918-40 | Nicotine | 1 in 1 BLISTER PACK | GUM, CHEWING | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55910-918 | NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)] | 2 | Current NDC, 4 package rows | 20240823_11e537db-7dc7-4b28-97eb-da70c80d8fe3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55910-918-20 | 55910091820 | 20 BLISTER PACK in 1 CARTON (55910-918-20) / 1 GUM, CHEWING in 1 BLISTER PACK | 20 blister pack | 2023-05-01 | 2028-07-28 | No | No | Historical |
| 55910-918-40 | 55910091840 | 40 BLISTER PACK in 1 CARTON (55910-918-40) / 1 GUM, CHEWING in 1 BLISTER PACK | 40 blister pack | 2023-05-01 | 2028-07-28 | No | No | Historical |